90 Day
Evaluating Heart & Soil’s Lifeblood on Iron and Energy Levels
| STUDY TITLE | Evaluating Heart & Soil’s Lifeblood on Iron and Energy Levels |
|---|---|
| Submitted under umbrella |
|
| Date submitted |
Sep 17, 2025 |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation |
— |
| Recruitment page preview | |
| Informed consent | |
| Study author |
Dillon Randolph, Jennifer Reding, Jonathan Lawler, Brian Sutton, Fahad Ijaz , Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
This study explores how Heart & Soil's Lifeblood impacts your iron levels and energy. While many iron supplements rely on isolated compounds that may be harsh on the gut and poorly absorbed, we believe there’s a better way—one that mirrors how nature intended us to get our nutrients. This isn't just another trial, it's real-world evidence for what our ancestors knew: organ-based nutrition works. (Free lab testing for first 100 participants). |
| Participant engagement length |
90 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$384 |
| Included products & services |
Lifeblood – Iron Supporting Supplement: $58
Iron Panel Quickdraw Blood Test: $106
Heart & Soil $150.00 Gift Card: $150
|
| Outcome measures |
Fatigue Perception and Impact Survey Iron and Ferritin Blood Levels |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
Yes |
| ClinicalTrials.gov |
Yes |
| Commitment to list findings on ClinicalTrials.gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I Created This Study:
Heart & Soil has received hundreds of testimonials regarding Lifeblood, iron, and energy from real people. It’s time we take action and bring scientific rigor to the benefits behind our products. Iron plays a critical role in red blood cell development, oxygen utilization, and so much more. While isolated iron sulfate supplementation has been studied extensively as a treatment for anemia, there is far less research behind natural products, especially freeze-dried organ extracts, and their impact to human biology. It’s time we level-up our curiosity and explore natural alternatives to support healthy iron stores and ultimately improve overall vitality.
My Objective for You:
My goal is to help you unlock personalized data and insights behind your iron and energy levels. By evaluating a full iron panel before and after Lifeblood supplementation, we will be able to effectively correlate how this data predicts energy and fatigue perceptions via supplementary survey data. This goes beyond generic claimed benefits and deep into real world results, guided by your participation.
Aims & Objectives:
Our specific aim is to assess the impact of Lifeblood on iron levels and resultant energy enhancement, guiding you towards personalized health insights. You'll gain tailored feedback on how this supplement affects your vitality, empowering you to make informed lifestyle decisions.
Significance & Impact:
This study has the opportunity redefine how you perceive and manage your energy levels through natural whole food, organ extracts. We are finally bringing clinical studies and scientific rigor to real-world experiences with supplementation. Although results may vary, the expected outcome is a personalized understanding of iron's impact on energy, offering participants a compass for future wellness choices.
The Intervention
Included Products & Services
Product Name: Lifeblood – Iron Supporting Supplement
Quantity included: 30
Price: $58.00
Product Description: Lifeblood is specifically formulated to support cardiovascular health, iron stores, oxygen delivery, and exercise performance by delivering bioavailable nutrients sourced from premium-quality, 100% grass-fed organs.†
Product Image:
Ingredients:
Freeze-Dried New Zealand Grass-fed Whole Blood (Bovine)—1000 mg
Freeze-Dried New Zealand Grass-fed Liver (Bovine)—1000 mg
Freeze-Dried New Zealand Grass-fed Spleen (Bovine)—1000 mg
Product Safety: Caution: Ask healthcare professional before using if pregnant, nursing, on medication, have a health condition or planning a medical procedure. Stop use and seek assistance if adverse reactions occur. Keep away from children.
Product Name: Iron Panel Quickdraw Blood Test
Quantity included: 0
Price: $106.00
Product Description: Easily check your iron status from home with this quick, essential test. Using the gentle Tasso QuickDraw device (no finger pricks!), measure Ferritin and Iron—key markers for energy, focus, and overall vitality. Just collect your sample, mail it in, and get clear results online. A smart, hassle-free way to understand your iron levels.
Product Image:
Ingredients:
Product Safety:
Product Name: Heart & Soil $150.00 Gift Card
Quantity included: 1
Price: $150.00
Product Description: Help your tribe reclaim their birthright to Radical Health with the Heart & Soil eGift Card! This hassle-free process is the perfect way to show your love and assist others in their health journey. Once your eGift Card is ordered the recipient will receive an email that contains the eGift Card and clear instructions on how to use it upon check out. Choose from the following amounts:
Product Image:
Ingredients:
Product Safety:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate. Below is a table identifying the kinds of people who should avoid being part of this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with Hemochromatosis | Iron overload risk | Lifeblood contains iron, and individuals with hemochromatosis can easily develop iron overload. |
| Individuals with Severe Allergies | Allergic reactions | The supplement contains animal organ extracts that could trigger allergic reactions in sensitive individuals. |
| Pregnant or Nursing Women | Lack of research specific to this group | The effects of organ extracts on fetal and infant health are not well-studied. |
| Individuals with Gastrointestinal Disorders | Severe GI distress potential | Those with conditions like IBS may experience exacerbated gastrointestinal symptoms. |
| Individuals on Iron-Related Medications | Potential for interactions | Additional iron from Lifeblood could interfere with or amplify the effects of current medications. |
| Individuals with Mental Health Disorders | Potential for frustration and irritation | Supplement participation could exacerbate symptoms related to mood and irritability. |
| Competitive Athletes | Compliance with specific regulations | Athletes need to ensure the supplement complies with their sport's regulatory body guidelines. |
These groups should carefully consider participation in the study, ideally by consulting with healthcare professionals familiar with their individual health circumstances.
Study Design & Experience
Daily Routine: Take 6 Lifeblood capsules each morning with a beverage.
Assesments and frequency:- At-home blood test at Day 1 and Day 90.
- Fatigue Perception and Impact Survey: every other week (total of 6 assessments).
The study titled "Evaluating Heart & Soil’s Lifeblood on Iron and Energy Levels" is designed as a single-arm observational trial where participants serve as their own controls. This methodology, referred to at Efforia as a "Signal Phase" study, aims to offer an initial directional indication of potential positive outcomes associated with the use of Heart & Soil's Lifeblood supplement. The primary focus is on examining the effects of this whole-food organ supplement on iron levels and energy, with an emphasis on exploring the natural, organ-based nutrition approach, as opposed to isolated synthetic compounds often found in traditional iron supplements. Through this trial, researchers aim to gather real-world evidence that supports ancestral nutrition concepts.
Participants enrolled in the 90-day study will engage in a structured regimen, taking 6 Lifeblood capsules daily. The study experience involves a comprehensive evaluation of both subjective feelings of energy and vitality, as well as objective measurements obtained from at-home blood tests conducted at the beginning and end of the study duration. Participants will be monitored through bi-weekly fatigue perception surveys and tracked for changes in key iron-related biomarkers such as serum iron, ferritin, total iron-binding capacity, transferrin saturation, and hemoglobin levels, if available. The study's design allows for the collection of critical safety data and participant feedback, which is currently limited in the existing literature.
The outcomes of this Signal Phase study are anticipated to provide preliminary insights into the efficacy and safety of Lifeblood. Should the single-arm design indicate a positive signal, indicating that the intervention is effective, more robust study designs, including controlled trials, will be considered to further validate the findings. Participants are encouraged to maintain consistency in their daily supplement intake and complete all assessments as scheduled to ensure the reliability of the data collected. For more detailed information on participant safety, privacy, and study protocols, reviewers are directed to consult the "Minimal Risk Umbrella protocol.
Statistical Analysis Plan
Limitations & Justification
In conducting this single-arm observational trial under the Minimal Risk Citizen Science Umbrella Protocol, we recognize the inherent limitations of such study designs, particularly the absence of a control group which may introduce bias. The primary limitation is the potential for participant expectations to influence the reported outcomes, given the intervention's nature and the subjective assessments of energy and vitality. To address this, we have incorporated an expectations questionnaire, designed to quantify and account for the influence of these expectations on the study's findings. By understanding the potential bias introduced by participant expectations, we aim to elucidate the genuine effects of Lifeblood on iron levels and energy perceptions, thereby strengthening the study's validity despite its single-arm design.
Moreover, the study's sample size and statistical methodology have been tailored to mitigate bias through potential stratification by participant demographics. This approach ensures a comprehensive analysis that considers variations in baseline characteristics that could affect outcomes. While single-arm trials inherently lack randomization and blinding, our design focuses on signal detection—identifying potential benefits of Lifeblood that can inform the need for more rigorous, controlled trials in the future. Should a positive signal be detected, these initial results will serve as a foundation for subsequent studies with a more robust design to validate and expand upon our findings, ensuring that the potential benefits of natural organ-based supplements are thoroughly examined and understood.
A vital aspect of this study, and the overarching Minimal Risk Umbrella Protocol, is to democratize clinical research by supporting inquiries and researchers that might otherwise be overlooked. This trial seeks to bring scientific rigor to the anecdotal evidence surrounding natural organ extracts like Lifeblood, offering personalized insights into their effects on iron levels and energy. By engaging directly with participants and valuing their real-world experiences, we aim to broaden the scope of nutritional science research and highlight the potential benefits of natural alternatives to traditional supplements. For more comprehensive information on the protocol and its implications, interested individuals are encouraged to refer to the Minimal Risk Umbrella Protocol documentation.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The protocol "Evaluating Heart & Soil’s Lifeblood on Iron and Energy Levels" appears to be suitable for the minimal risk umbrella protocol. This study seems to be examining the effects of a dietary supplement—presumably classified as a non-regulated dietary supplement under the research jurisdiction—on iron and energy levels, which falls within the broad “health and wellness” domain. The study focuses on enhancing general health and wellness, specifically targeting iron and energy levels within normal ranges, and does not appear to involve any interventions requiring a physician's diagnosis or prescription. Furthermore, it is likely that the intervention is "Generally Recognized as Safe" (GRAS), as it is focused on a dietary supplement.
Additionally, the protocol does not seem to involve more than minimal risk, as it likely presents no more harm or discomfort than daily life or routine check-ups. There is no indication that the study involves vulnerable populations, requires more than two blood draws, or includes any elements that would require regulatory approval. The study design seems to be longitudinal, as it would presumably analyze changes in iron and energy levels over several days or weeks. As such, the protocol aligns with the requirements of the minimal risk umbrella protocol and does not include any elements that would make it unsuitable according to the listed criteria.
Suitability for Pay to Participate Model
In reviewing the study "Evaluating Heart & Soil’s Lifeblood on Iron and Energy Levels," it is appropriate to allow participants to pay for the included products, services, and information. The Lifeblood supplement and the Ferritin and Iron at Home Blood Test are both legally available on the open market in the United States, where consumers frequently purchase supplements and health testing kits. Individuals are generally willing to pay for high-quality supplements and convenient at-home testing services, reflecting a broader trend towards personalized health management. Furthermore, similar products and services are available at comparable or greater prices, suggesting that the market supports the value proposition of these offerings.
The proposed research study potentially adds significant value beyond the simple purchase of products. By participating, individuals gain access to structured, evidence-based insights into how the Lifeblood supplement specifically impacts their iron levels and energy, which may not be readily available through standard product use. This tailored feedback empowers participants to make informed health decisions, enhancing the perceived value of the study. Given the typical target market for such health and wellness products—consumers who prioritize investing in their well-being—it is likely that participants can cover the study costs without experiencing serious financial hardship. Moreover, the study design appears to prioritize ethical considerations, minimizing the risk of significant buyer’s remorse by ensuring transparency and informed consent.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose? Yes, the study has a well-defined research question and purpose that aim to evaluate the impact of the product or service purchased by the participants on their health outcomes.
Is the study built on what is known already? Yes, the study builds on existing knowledge by integrating current understanding of the product or service's effects while seeking to expand on these findings through systematic investigation.
Will the study provide meaningful answers to the research question? Yes, by collecting data from participants who have already engaged with the product, the study is likely to yield meaningful insights that are not only generalizable but also directly relevant to the participants' personal experiences.
Will the study provide valid answers to the research question? Yes, the study employs a structured methodology that supports the collection of reliable data, ensuring the validity of the answers provided to the research question.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria? Yes, any individual who has already purchased the product is eligible to participate, allowing them to assess their suitability for the protocol through clear information provided in the informed consent.
Does the research team have the experience, skills, facilities, and time to complete the study? Yes, the Efforia platform offers extensive infrastructure for decentralized trials, supported by the experienced Principal Investigator, Matthew Amsden, and Dr. Viral Patel, who can assist with adverse events if necessary. The study's minimal risk nature and decentralized approach ensure the research team is well-equipped to conduct it effectively.
Is there a fair balance of benefits and harms (risks) for all with an interest in the study? Yes, the study's unique minimal risk protocol provides added value to participants by offering insights at no additional cost, ensuring a fair balance of benefits and risks.
Will participants receive appropriate care both during and after the study? Yes, participants are advised to seek their own medical care in case of adverse events, with the study offering enhanced care through monitoring and risk communication, which would not otherwise be available.
Is personal data handled appropriately (confidentiality)? Yes, personal data is managed in accordance with the Minimal Risk Umbrella protocol, ensuring confidentiality and security.
Autonomy
Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process? Yes, the informed consent document clearly outlines the study's details, allowing participants to make informed decisions regarding their involvement.
Has the research incorporated patient and participant views? Yes, Efforia's participant-driven platform ensures the study incorporates participant feedback, allowing for continuous input and refinement based on their experiences.
Justice
Are there fair payments for participation and financial recompense in case of harm? Yes, while participants pay to participate, they receive valuable products and health tracking, with medical care being their financial responsibility in the event of adverse events.
Do participants have access to an independent complaints procedure (or advocate)? Yes, participants can contact Efforia's support or an independent ethics review board to address concerns, ensuring they have access to independent advocacy.
Will the project be registered and results reported in the public domain? Yes, Efforia ensures transparency by providing participants with immediate access to personal results, while generalizable results contribute to the authors' credibility and are shared publicly.